1/2- Bangladesh Center for Global Environmental and Occupational Health- Bangladesh

NCT ID: NCT05570552

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2027-06-30

Brief Summary

Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass (wood, agricultural residue, cow dung, etc.) fuel use for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use, especially in low- and middle-income countries (LMICs). Earlier the investigators showed that Liquid Petroleum Gas (LPG) for 24 months, reduced personal PM2.5 exposure by 58.17 percent which induced novel changes in immune and inflammatory responses in the participants; however cardiopulmonary markers remained relatively stable in post-intervention assessment.

In this study, the investigators aim to evaluate the effects of mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention on adoption and exclusive use of LPG. The investigators also aimed to observe whether long-term effects of HAP reduction can impact the subclinical measures of cardio-vascular and pulmonary dysfunction and regulate innate and inflammatory immune function among women and children in semi-rural settings in Bangladesh. The investigators will also investigate the influence of exposure to HAP on antibody response to vaccines (adaptive immunity). The BCC intervention will be provided by conducting a large household level randomized controlled trial by educational intervention using mHealth based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.

Detailed Description

Background:

Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass fuel (wood, agricultural residue, cow dung, etc.) used for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use such as Liquid Petroleum Gas, especially in low- and middle-income countries (LMICs).

Rationale: In the earlier GEOHealth (Round-I) study, the investigators have shown that LPG for 24 months, reduced personal PM2.5 exposure by 58.2 percent which induced novel changes in innate immune and inflammatory responses in women but the changes in chronic cardio-pulmonary markers were not prominent, most likely due to short duration of follow up and probably impact of ambient pollution. Moreover, sustained use of LPG could be challenging as earlier GEOHealth (Round-I) study provided the cook stove and supply of LPG free of cost. A post-completion screening showed >70% households continued using LPG albeit not exclusively. It is plausible that an intervention using mobile phone-based application can improve the exclusive use of LPG in the communities.

Hypothesis:

1. The mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention can be easily incorporated in Government policy that can promote adoption, and increase exclusive use of LPG in the communities.

The long-term effect of HAP reduction can be associated with-

2. subclinical measures of cardio-vascular and pulmonary dysfunction.

3. balanced changes in innate/ inflammatory and adaptive immune function (vaccine response).

Objectives: To evaluate

1. The effects of a scalable educational intervention (using mHealth application) on adoption and exclusive use of LPG.

2. The long-term effects of HAP reduction on subclinical measures of cardio-vascular and pulmonary dysfunction.

3. The long-term effects of HAP reduction on innate/ inflammatory immune function among women and children and to investigate the influence of HAP exposure on antibody response to vaccines (adaptive immunity).

Methods: The investigators will conduct a large household level randomized controlled trial by educational intervention using mobile phone (mHealth) based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area-wise (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.

Outcome measures/variables: Personal and surrounding area PM2.5 and BC level will be measured at pre- and post-intervention. Lung function and lung pathology will be assessed through spirometry, Chest X-ray, and High-resolution Computed tomography of the chest (HRCT). Preclinical makers of cardiovascular diseases (CVD) will include blood pressure and EKG. Markers of metabolic dysfunction will be assesses by measuring HbA1c and fasting lipid profile. Immune function will be assessed by phenotyping of Immune cells, functional cytotoxic killer cells, oxidative stress of lymphocytes.

Conditions

Air Pollution; mHealth Intervention; Cardiopulmonary Function; Immune Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

mHealth arm

mHealth arm will receive mobile phone based behavior change communication intervention to exclusively use clean fuel LPG for domestic cooking.

Group Type: EXPERIMENTAL

mHealth based behavioral change communication intervention

Intervention Type: BEHAVIORAL

We will implement a mHealth based communication system. The number of text messages and push notifications that a participant receives, will be variable and will occur at least weekly (based upon their responses) or the participant opts out of receiving messages. Participant change of behavior and use of improved stoves will be monitored by tracking clicks/views of educational materials and video vignettes.

Control arm

Control arm will receive no mHealth based intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mHealth based behavioral change communication intervention

We will implement a mHealth based communication system. The number of text messages and push notifications that a participant receives, will be variable and will occur at least weekly (based upon their responses) or the participant opts out of receiving messages. Participant change of behavior and use of improved stoves will be monitored by tracking clicks/views of educational materials and video vignettes.

Intervention Type: BEHAVIORAL

Other Intervention Names

value sensitive design (VSD), Fogg Behavior Model (FBM), System Usability Scale (SUS)

Eligibility Criteria

Inclusion Criteria

• Participants in the previous GEOHEALTH round-I study
• Aged between 25 and 70 years
• Live in biomass-using home with traditional stoves
• Non-smoker and live with non-smokers
• Exposed to <10 µg/L of water arsenic

Exclusion Criteria

• Known to have immune related illness or taking any prescription medication (particularly those that suppress or enhance immune function)
• Known to have any clinical events of CVD or lung disease, including stroke or coronary heart disease.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

Mailman School of Public Health

UNKNOWN

Sponsor Role: collaborator

Marquette University

OTHER

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Centre for Diarrhoeal Diseases Research, Bangladesh

Dhaka, , Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Rubhana Raqib, PhD

Role: CONTACT

rubhana@icddrb.org

+8802222277001-10 ext. 2404

Mohammad Yunus, MBBS, M.Sc.

Role: CONTACT

myunus@icddrb.org

+8802222277001-10 ext. 2210

Facility Contacts

Rubhana Raqib, PhD

Role: primary

rubhana@icddrb.org

+8802222277001-10 ext. 2404

Other Identifiers

PR-22057 (2U01TW010120-06)

Identifier Type: -

Identifier Source: org_study_id